Method and system for delivering substitute medical therapies with restricted access

ABSTRACT

A system and methods are provided for delivering to a patient a substitute medical therapy with restricted distribution or access. One example is a medical therapy provider, such as a pharmacist, receiving a prescription for a medical therapy for a patient and describing these procedures and the substitute medical therapy to the patient. The patient and patient&#39;s prescribing physician will determine whether the proposed substitute medical therapy is desired and would be indicated for this patient, including obtaining data and informed consent from the patient. The method also provides a distributor or third party reviewer the prescription and certification from a qualified patient&#39;s physician, data and consent from a qualified patient, including an authorization for the substitute medical therapy and confirming the informed consent from a qualified patient by the distributor or a third party reviewer. From this data, the distributor or third party reviewer determines the qualified patient&#39;s eligibility for access to the medical therapy and, if the qualified patient is found eligible, delivers the medical therapy to the patient.

CONTINUATION DATA AND CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/392,531 filed Mar. 29, 2006, now abandoned and claims the benefit ofprovisional applications 60/666,513 filed Mar. 29, 2005 and 60/689,913filed Jun. 13, 2005, which are hereby incorporated by reference in theirentirety herein.

1. FIELD OF INVENTION

The present invention relates generally to a system and method fordelivering, to a patient, a substitute medical therapy with restricteddistribution or access. More particularly, the present invention relatesto a method for delivering, to a patient, a substitute medical therapywhile preventing access to the substitute medical therapy forindividuals for whom the medical therapy would be contraindicated orotherwise restricted.

2. BACKGROUND

Typically, when a physician prescribes a prescription for a particularmedical therapy, the physician may specify a particular brand name forthe medical therapy, because the physician is familiar with this brandor, in some instances, the physician may not be aware that there is asubstitute medical therapy available. These substitute medical therapiesrepresent additional options for patients, which may provide enhancedbenefits, and/or lower cost, depending on the patient's medical carecoverage.

For example, a physician could specify a brand name for a therapeuticdosage of an active pharmaceutical ingredient (API), i.e., a “brandedproduct”, when there is a substitute generic pharmaceutical product,approved by a regulatory authority, such as the Food and DrugAdministration (FDA), with the same API. In some instances, the genericpharmaceutical may be a direct substitute, i.e., therapeutically andpharmaceutically equivalent or “bioequivalent.” In other instances, theproduct may contain the same API, at a similar dosage or with adifferent release profile or dosage form. In yet other instances, theremay be substitute pharmaceutical products that treat the same medicalcondition for which the original branded product was prescribed.

Furthermore, the substitute medical therapy could be an alternativebiological or medical device, or another medical therapy. For example, aphysician could specify a particular brand of therapeutic proteins, whenanother brand would provide the patient with greater safety,effectiveness, or a substantial savings, based on the applicable medicalinsurance coverage for the prescribed medical therapy. Likewise, therecould be a substitute medical device, e.g., syringes, or another medicaltherapy with a similar therapeutic use.

For substitute products with the same API, pharmacists are often able tooffer patients an option to substitute medical therapies. For example,many state laws require pharmacists to substitute genericpharmaceuticals, when a generic pharmaceutical is available for abranded product, i.e., a medical therapy with a proprietary name. Inother instances, pharmacists may offer a patient the option for ageneric pharmaceutical, because it would save the patient money, basedon the patient's medical insurance coverage. In yet other instances, apatient may be required for medical insurance coverage to substitute forthe prescribed branded drug medical therapy with a similar therapeuticuse but a different API, often because the substitute API has anavailable generic pharmaceutical. For example, an insurance companycould require a patient to use a generic form of birth controlpharmaceutical over a new, branded birth control pharmaceutical product.

In some cases, the physician may choose to prevent generic or othersubstitution by specifically requiring that the prescription may bedispensed or delivered only with the branded product. In otherinstances, direct substitution may not be possible, because there is nosubstitute product, or the product is provided with restricted access.In the latter case, a generic product may be available, but it may beavailable only under a different restricted access program.

FDA required, for example, the manufacturers of the initial genericproducts for Accutane® (generic: isotretinoin), to provide riskmanagement programs that contained the “same essential elements” of therisk management program developed for the branded product. Becauseisotretinoin is a potent teratogen with potential to cause severe birthdefects, both the branded and generic risk management programs weredesigned to help prevent fetal exposure to isotretinoin. The initialrisk management programs for the generic isotretinoin were separatelymaintained and managed, but the prescriptions were delivered similarlyat the pharmacy.

Conventional approaches for delivering a substitute medical therapy,such as a generic pharmaceutical, with restricted access or distributionhave not always been successful. In some situations, moreover, thesubstitute medical therapy may even provide an alternative restrictedaccess or distribution that achieves the same goals. For example, thereis no generic substitute for the branded pharmaceutical Thalomid®(generic: thalidomide). The restricted access program for Thalomid®requires dispensing pharmacies to be “registered” and prescriptions tobe “validated” in a computer readable medium that can only be accessedby “registered” pharmacies. Pharmacies that choose not to be“registered”, for example, may not dispense Thalomid®, because they donot have access to the computer-generated validation code. As a result,generic manufacturers must develop alternative methods to deliverthalidomide to potential patients through an alternative distributionchannel.

One example of a proposed invention for providing substitution ofequivalent medical therapies related to U.S. Patent Application No.2005/0065645, submitted by Liff, et al., entitled, “Method forControlling a Drug Dispensing System.” This relates to an automatedpharmaceutical dispensing system to receive and dispense a prescriptionvia an adapted cabinet, which involves providing the operator anopportunity to select a generic substitution product. The system updateslabel data to include the generic drug information, maintains aninventory and keeps track of the drugs that have been dispensed.

Another example where pharmaceuticals may be substituted concerns U.S.Pat. No. 6,260,761, issued, to Peoples, entitled, “System and Method forAccurately Dispensing Prescriptions in a Pharmacy.” This relates to adevice and method for converting product-specific identification numbersassociated with bar code indicia on pharmaceutical products to anindustry standard identification number. The process involves reading abar code indicia, converting the indicia into an input string andstandardizing the input string by means of adding or subtractingcharacters in accordance with rules based on the bar code length andinput string. Pharmaceutical products of two different sources may becompared to determine if they contain the same drug as determined by thestandard identification number. After receiving prescription information(bar code) that identifies a requested medical item, a substitution listis created that identifies at least one requested medical item and anequivalent item, and outputs the dispensing information for the selectedmedical item on the substitution list in response to substitution rulesin a database.

Another example where pharmaceuticals may be substituted relates to U.S.Patent Application No. 2004/0215369, submitted by Rosenblum entitled,“Automatic Prescription Drug Dispenser.” This relates to an automaticprescription drug dispenser, including a remote dispenser, aprescription entry system, and a communications network. The remotedispenser transmits and receives information from the communicationsnetwork and dispenses prescription drugs to the patient. Theprescription entry system transmits and receives information from thecommunications network and provides an input system for the prescriberto electronically enter individual prescriptions for each patient. Thecommunications network coordinates communications between theprescriber, insurance carrier, and the remote dispenser. As part of theprescription writing process, the patient's insurance plan can beuploaded to the computer along with other patient information. Each drugviewed by the prescriber will usually indicate whether it is on thepatient's insurer's formulary along with its approval status and whetherthe drug is in the remote dispenser. If the drug is not on the insurer'sformulary, the prescriber may be prompted to a drug of the sametherapeutic class that is covered on the patient's insurer's formulary.If the drug is not in the remote dispenser, the prescriber may determinefrom the patient whether the patient desires any of the productsavailable from any of the remote dispensers, or, if not available, aprinted traditional prescription that may be taken to a pharmacy of thepatient's choice for dispensing.

Yet another example where pharmaceuticals may be substituted concernsU.S. Patent Application No. 2004/0153336, submitted by Virdee, et alentitled, “Prescription. Creation and Adjudication Method.” This relatesto a computer-implemented method for creating a prescription fortreatment of an injury or illness covered by a workers' compensationsystem, which facilitates on-line adjudication of workers' compensationclaim. The patient name, employer name and type and quantity ofmedication prescribed are input. During prescription writing, aformulary text box can be used to provide an indication whether theprescribed medication is included in the patient's formulary bycomparing the prescribed medication to a list of medications containedin a formulary database. The user can obtain further information on thedrugs in the drug database or can identify alternative medications byselecting an alternative medication link. The selected drugs will appearin a currently selected medications list, where a prescription providermay then be selected to route the claim for on-line adjudication and tofill the prescription.

SUMMARY OF THE INVENTION

The present invention is directed toward a method and apparatus thatdelivers a substitute medical therapy to a patient with restricteddistribution or access by a pharmacy or other medical therapy provider.The medical therapy and substitute medical therapy is typically providedwith restricted distribution or access to prevent access for individualsfor whom the medical therapy would be contraindicated or otherwiserestricted. The delivery is accomplished by a medical therapy providerfirst identifying a substitute medical therapy and obtaining dataregarding the restricted access for obtaining the substitute medicaltherapy.

Accordingly, one embodiment of the present invention relates to a methodand apparatus for determining whether a patient desires access to thesubstitute medical therapy once the patient becomes aware of thesubstitute medical therapy with restricted access. If the patientrequests the substitute medical therapy, the patient's prescribingphysician determines whether the physician will certify that the patientqualifies for access to the substitute medical therapy. The physiciancertification includes an agreement to follow the requirements of therestricted access for the substitute medical therapy. The physician'sdetermination may include obtaining additional patient data and informedconsent for the substitute medical therapy. The patient's andprescriber's data is compared with the requirements for determiningaccess to the medical therapy by a third party, for example, adistribution party.

Another embodiment of the present invention provides the embodimentdescribed above and, further obtaining data regarding the procedure fordelivering a substitute medical therapy.

A further embodiment of the present invention relates to the embodimentdescribed above and, further, for each patient found eligible for accessto the substitute medical therapy, distributing the substitute medicaltherapy.

Yet another embodiment of the present invention relates to theembodiment described above and, further, providing prescription data tothe prescribing physician.

Another embodiment of the present invention relates to the embodimentdescribed above, and further, confirming prescription data, includingthe prescription label and eligibility determination.

Yet another embodiment of the present invention relates to theembodiment described above, and, further, obtaining additionalinformation from the patient to determine present or futurequalification or eligibility for the substitute therapy or for qualitycontrol purposes.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be understood more completely with reference to thefollowing detailed description and Figures in which like numerals referto like elements.

FIG. 1 shows a network environment adapted to support the proposedinvention.

FIG. 2 illustrates a processing apparatus adapted to store and processdata related to the present invention.

FIG. 3 illustrates a communication appliance shown in FIG. 1.

FIG. 4 is a flowchart of one embodiment of the present invention.

DETAILED DESCRIPTION

The present invention relates to a system and method for delivering asubstitute medical therapy to a patient with restricted distribution oraccess. The method prevents access to the substitute medical therapy forindividuals for whom the medical therapy would be contraindicated orotherwise restricted.

While it is possible to apply this invention to a variety of medicaltherapies, one embodiment of the present invention may be used todeliver a drug with the potential for serious adverse events to thepatient or a developing fetus or with the potential for substance abuseor clinical dependence.

The present invention provides a solution for delivering a substitutemedical therapy with restricted access or distribution that may not bedelivered via the same restricted access or distribution process as theprescribed medical therapy. Because of the unique and sometimes complexproblems associated with transferring a prescription from one restricteddistribution or access program to another, conventional techniques havenot provided a method that permits the medical therapy provider, e.g., apharmacist, to substitute these medical therapies for a patient. Thepresent invention provides a method that goes beyond merely identifyingor providing as an option a substitute medical therapy or substitutingit in an adjudication process to assist the physician with writing theprescription for medical therapies included in a patient's formulary.

The medical therapy substitution is performed based on the informedconsent of the patient requesting the substitute medical therapy andfollowing an independent review by a distribution party or third partyreviewer for the substitute therapy to ensure that the substitution isproper. Such methods are needed to increase patient accessibility tosubstitute medical therapies that may be required by a patient's medicalcare coverage or provide less costly alternatives, including genericpharmaceuticals.

An embodiment of the invention is a method for delivering a genericversion of the pharmaceutical Thalomid® (generic: thalidomide) under thegeneric product's restricted distribution or access program. A pharmacy,for example, could use this invention for substituting genericthalidomide after being presented with a prescription for Thalomid® by apatient. While the present invention provides a delivery method forsubstituting the teratogenic drug thalidomide, the invention also may beemployed for distributing any medical therapy that involves a restricteddistribution or access program, such as, for example, thalidomide,lenalidomide, isotretinoin, bostentan, alosetron, dofetilide, drugs witha high abuse potential or chemical dependence, which may be regulated inpart by the U.S. Drug Enforcement Agency (DEA), such as oxycodone,marijuana, or cannabis, or any medical therapy that requires ongoingdiagnostic testing for continued therapy, such as clozapine.

According to the present invention, a medical therapy provider, such asa pharmacist, would first receive a prescription from a patient for amedical therapy. When the medical therapy provider (generally referredto herein as “provider”) first receives this prescription, the providerfollows its customary practice for delivering the prescribed medicaltherapy. Such practices typically include checking the provider'sinventory to determine whether the prescribed medical therapy may beimmediately delivered or must be ordered.

A provider may become aware of a substitute medical therapy for the oneprescribed. This awareness may be based on the provider's own knowledge,the provider's inventory database, or any other indicating means. Insome instances, the substitute medical therapy could be a genericpharmaceutical version of the branded product, typically approved underSection 505(j) of the Federal Food, Drug and Cosmetic Act (FDCA) as abioequivalent drug, i.e., therapeutically and pharmaceuticallyequivalent (same API), to the branded product. In other instances thesubstitute medical therapy could be approved under 505(b)(2) of theFDCA, which generally contains the same API as the branded product (orsame therapeutic use) but is not bioequivalent or required additionalclinical trials for approval by the FDA. In yet other circumstances, thesubstitute medical therapy could be an alternative therapy in the sameclass of therapeutics, e.g., birth control pharmaceuticals, a biologic,e.g., a product derived from live biological material, a medical device,or another substitute medical therapy for the written prescription.

Unlike other substitute medical therapies, such as most genericpharmaceuticals that do not have restricted distribution or access, theprovider would not be able to merely provide the substitute medicaltherapy to the patient with the prescription. Instead, the providerwould need to be in possession of or obtain information about therestricted distribution program associated with the substitute medicaltherapy and the requirements for delivering the substitute medicaltherapy to a patient. In some instances, the substitute medical therapywould be provided under the same restricted distribution program butwould not have the same manufacturer or distributor as the brandedproduct. In other instances, the substitute medical therapy would beprovided under a similar, but alternative, restricted access program. Inmost cases, the alternative restricted access program is designed toaccomplish the same goals as the branded restricted distributionprogram. For example, the generic isotretinoin programs sought toeducate patients about isotretinoin's teratogenic effects and whyisotretinoin may not be taken by pregnant females as part of therequired essential elements for all isotretinoin restricted accessprograms.

After becoming aware of the substitute medical therapy with restrictedaccess, the provider may need to obtain additional information about thesubstitute medical therapy's restricted distribution program todetermine whether it may be beneficial for the patient, e.g., it maycost less under the patient's present medical coverage or it may offerother enhanced benefits for this patient. Enhanced benefits may include,for example, a different route of administration or dosing schedule thatmay be preferred by a particular patient. The provider typically thenexplains to the patient the substitute medical therapy, its risks andbenefits, and the requirements for access to the substitute medicaltherapy.

If the patient determines that the potential benefit of the substitutemedical therapy outweighs the risks and requirements for the substitutemedical therapy, the provider obtains the required consent fordelivering the substitute medical therapy. The informed consent mayinclude an authorization to release the medical records from theprescribing physician of the patient with a qualifying prescription todeliver the substitute medical therapy. The consent may acknowledgereceipt of data about the substitute medical therapy's adverse effectsor potential for adverse effects, as well as the proper standard of carefor delivering and administering the substitute medical therapy.Typically, the informed consent may also include a request that thesubstitute medical therapy be delivered based on the originalprescription. The patient, or patient's prescribing physician, may berequired to agree to certain requirements associated with the restrictedaccess for the substitute medical therapy, for example, a certificationto follow all of the listed requirements for access to the substitutemedical therapy, and, in some cases, may write a new prescription forthe substitute therapy. In addition, the patient may undergo additionaldiagnostic testing for access to the substitute medical therapy.

The provider typically provides the patient's informed consent andprescription to a distribution party or third party reviewer, but mayalso provide this information to the patient's prescriber. Thisinformation could be forwarded, for example, to a distributor, e.g., awholesale distributor, manufacturer, or a third party that assumes therole of a distributor. The instructions for this process would typicallybe included in the data obtained by the provider for delivering thesubstitute medical therapy.

The distributor may review the prescription, informed consent,authorization to release the patient's medical records from thepatient's prescribing physician, and request for patient with aqualifying prescription to be provided access to the substitute medicaltherapy and could determine whether the patient met the requirements andis, therefore, eligible for access to the substitute medical therapy.Prior to making a determination, the distributor could obtain certaincertification data and any required diagnostic tests, typically from thepatient's prescribing physician. The certification data would includeconclusions from the patient's prescribing physician that the patient isa qualified patient for the substitute medical therapy based on thequalifying prescription and other data. The certification would alsoinclude the prescribing physician's representations that he/she willfollow the requirements to access the substitute medical therapy. Forexample, the distributor could determine that the required data werecomplete and accurate and verify certain information where appropriate.The distributor could also register the patient and physician and storethis data in a computer readable medium, for record keeping purposes andto facilitate other data collection.

Furthermore, following an initial review of the data, the distributorcould consult with the patient or the patient's physician. Theconsultation may be voice-recorded, to aid in the determination whetherthe qualified patient with a prescription for a different specificmedical therapy should be provided access to the substitute medicaltherapy. For example, this distributor could verify medical coverage, aphysician's medical license or Drug Enforcement Administration (DEA)registration number, that the physician has examined this patient, or apatient's understanding of the data associated with the substitutemedical therapy and its restricted access.

When this distributor determines that the patient is eligible for accessto the substitute medical therapy, the distributor could deliver, asappropriate, the substitute medical therapy to the patient or designateddelivery agent for the patient. The distributor may designate apharmacy, manufacturer, a wholesale distributor, or a third party todeliver the substitute medical therapy. In many cases, the provider mayrequest to initially receive the substitute medical therapy for thepatient, because of the provider's relationship with the patient. Thedistributor may use, for example, a conventional, confirmed deliverymechanism for the substitute medical therapy that obtains a signatureupon delivery. This may include, for example, a carrier such as FederalExpress, United Parcel Service, or DHL.

The substitute medical therapy generally comprises the substitutemedical therapy, along with its attendant labeling, which typically hasbeen approved for use by the FDA. Such labeling may include a patientguide, prescribing information, or audiovisual materials, for example,to supplement the patient guide and prescribing information.

Alternatively, if it is not possible for the eligible patient to signfor the delivery, the distributor could send the substitute medicaltherapy, for example, to the patient's physician or pharmacist, providedthe substitute medical therapy is delivered according to applicable lawsor labeling requirements for the medical therapy.

Additionally, the confirmed delivery of the substitute medical therapyto the eligible patient may be recorded in a database available in acomputer readable medium, along with other prescription relevant data.For example, the distributor could record data in a central databaseincluding the patient's name, prescription delivered, a copy of theprescription labeling for this patient, and data concerning thedistributor's determination that the patient should be provided accessto the substitute medial therapy in this instance. The distributor'sdetermination may include a voice recording of the informed consent fromthe qualified patient.

Alternatively, a confirmation letter or a copy of the prescription orother prescription relevant data may be provided to the eligiblepatient's physician to aid in determining the patient's potential forfuture medical therapy.

Following a distribution of the substitute medical therapy, thedistributor may obtain additional data from the eligible patient or theeligible patient's physician to assess the patient's eligibility toobtain the substitute medical therapy in a subsequent prescription, forquality control, or as required by a regulatory authority that monitorsthe distribution of the restricted access substitute medical therapy.

This invention may be implemented using one or more processing devices.The processing devices may be coupled such that portions of theprocessing and/or data manipulation may be performed at one or moreprocessing devices and shared or transmitted between a plurality ofprocessing devices. Thus, an example of the invention is described in anetwork environment. Specifically, FIG. 1 shows a network environment100 adapted to support the present invention. The exemplary environment100 includes a network 104, a server 102, a plurality of communicationappliances, or user locations, or subscriber devices, or clientterminals, 110(a) . . . (n) (where “n” is any suitable number)(collectively referred to herein as, client terminals 110) and theremote client terminals, represented by terminal 120.

The network 104 is, for example, any combination of linked computers, orprocessing devices, adapted to transfer and process data. The network104 may be private Internet Protocol (IP) networks, as well as public IPnetworks, such as the Internet that can utilize World Wide Web (www)browsing functionality.

Server 102 is operatively connected to network 104, via bi-directionalcommunication channel, or interconnector, 112, which may be for examplea serial bus such as IEEE 1394, or other wire or wireless transmissionmedium. An example of a wireless transmission includes wirelessapplication protocol (WAP). The terms “operatively connected” and“operatively coupled”, as used herein, mean that the elements soconnected or coupled are adapted to transmit and/or receive data, orotherwise communicate. The transmission, reception or communication isbetween the particular elements, and may or may not include otherintermediary elements. This connection/coupling may or may not involveadditional transmission media, or components, and may be within a singlemodule or device or between the remote modules or devices.

The server 102 is adapted to transmit data to, and receive data from,client terminals 110 and 120, via the network 104. Server 102 isdescribed in more detail with reference to FIG. 2, herein.

Client terminals 110 and 120 are typically computers, or otherprocessing devices such as a desktop computer, laptop computer, personaldigital assistant (PDA), wireless handheld device, and the like. Theymay be capable of processing and storing data themselves or merelycapable of accessing processed and stored data from another location(i.e., both thin and fat terminals). These client terminals 110, 120 areoperatively connected to network 104, via bi-directional communicationchannels 116, 122, respectively, which may be for example a serial bussuch as IEEE 1394, or other wire or wireless transmission medium. Clientterminals 110, 120 are described in more detail in relation to FIG. 3.

The server 102 and client terminals 110, 120 typically utilize a networkservice provider, such as an Internet Service Provider (ISP) orApplication Service Provider (ASP) (ISP and ASP are not shown) to accessresources of the network 104.

FIG. 2 illustrates that server 102, which is adapted to store andprocess data related to the present invention, is operatively connectedto the network (shown as 104 in FIG. 1), via interconnector 112. Server102 includes a memory 204, processor 210 and circuits 212. The server102 may be operated by a distributor, such as a drug manufacturer orpharmacist, or other medical therapy distributing entity.

Memory 204 stores programs 206, which include, for example, a webbrowser 208, algorithm 400, as well as typical operating system programs(not shown), input/output programs (not shown), and other programs thatfacilitate operation of server 102. Web browser 208 is for example anInternet browser program such as Internet Explorer®. Algorithm 400 is aseries of steps for manipulating selected data, which is typicallystored on a computer-readable memory and executed by a processor. Theprocess of the present invention typically generates a record of adelivered substitute medical therapy to a patient in accordance with aphysician's prescription and requirements for restricted access. Thesefunctions may be implemented or facilitated by using software or otherprogram code to sort the data and generate the representation. Thealgorithm 400 is discussed in more detail in relation to FIG. 4.

Memory 204 also stores data tables 214, 216, 218, and 220. These datatables are databases or memory locations adapted to store related data,which can be retrieved, processed, updated, modified or otherwisemanipulated.

For example, data table 214 may be adapted to store prescription datarelated to a first patient; data table 216 may be adapted to storeprescription data related to a second patient; and data table 218 may beadapted to store prescription data related to a third patient. Datatable 220 may be adapted to store a subset of data collected from eachpatient. A patient's prescription data could include, for example, thepatient's social security number, address, prescribing physician, anddiagnostic test results. This data is typically obtained in relation tothe physician's determination that a particular substitute medicaltherapy would be indicated or could be beneficial for a patient.

Processor 210, which is operatively connected to memory 204, is used toprocess and manipulate the data retrieved and stored by server 102 orfrom another device coupled to system 100. The processor 210 istypically a microprocessor with sufficient speed and processing capacityto adequately perform the desired data manipulations of server 102.Circuits 212 are operatively connected to processor 210 and typicallyinclude, for example, Integrated Circuits (ICs), ASICs (applicationspecific ICs) power supplies, clock circuits, cache memory and the like,as well as other circuit components that assist in executing thesoftware routines stored in the memory 204 and that facilitate theoperation of processor 210.

FIG. 3 illustrates subscriber terminal, also referred to herein as aclient terminal, user terminal, or communication appliance 110. Terminal110 is typically a desktop computer, laptop computer, PDA (personaldigital assistant), wireless handheld device, mobile phone or otherdevice capable of interfacing with a network, such as an IP network.Terminal 110 includes processor 310, support circuitry 312, memory 304,input module 330 and display module 340. Bi-directional interconnectionmedium 116 operatively connects the terminal 110 to the network (shownas element 104 in FIG. 1). The user terminal is typically located at theuser location. The user may be, for example, a prescribing physician.

Processor 310, which is operatively connected to memory 304, is used toprocess and manipulate the data retrieved and stored by terminal 110.The processor 310 is typically a microprocessor with sufficient speedand processing capacity. The processor 310 is operatively connected tocircuitry 312. Circuitry 312 typically includes, for example, IntegratedCircuits (ICs), ASICs (application specific ICs) power supplies, clockcircuits, cache memory and the like, as well as other circuit componentsthat assist in executing the software routines stored in the memory 304and that facilitate the operation of processor 310.

Memory 304 stores programs 306, which include, for example, a webbrowser 308, algorithm 400 as well as typical operating system programs(not shown), input/output programs (not shown), and other programs thatfacilitate operation of terminal 110. Web browser 308 is for example anInternet browser program such as Internet Explorer®. Algorithm 400 is aseries of steps, typically executed by a processor such as, for example,processor 310, to manipulate selected data from the client terminal.Algorithm 400 is discussed in more detail in relation to FIG. 4.

Memory 304 also stores data tables 314, 316, 318, and 320. These datatables are databases or memory locations adapted to store related data,which can be retrieved, processed, updated, modified or otherwisemanipulated.

Data table 314 is adapted to store prescription data related to a firstpatient; data table 316 adapted to store prescription data related to asecond patient; and data table 318 is adapted to store prescription datarelated to a third patient. Data table 320 is adapted to store a subsetof the data collected for each patient. A patient's prescription datacould include, for example, the patient's social security number,address, age, gender, allergies, concurrent medical therapies, anydisorders or disabilities such as diabetes, hypertension, etc., name ofthe prescribing physician, diagnostic test results, and medical therapyprovider. This data is typically obtained in relation to the physician'sdetermination that a particular substitute medical therapy would beindicated or could be beneficial for a patient.

Input module 330 is, for example, a keyboard, track ball, mouse, touchpad, menu having soft-keys, or any combination of such elements, orother input facility adapted to provide input to terminal 110. Thephysician can use these input facilities to input patient informationinto terminal 110.

Display module 340 is, for example, a monitor, LCD (liquid crystaldisplay) display, GUI (graphical user interface) or other interfacefacility that is adapted to provide or display information to a user.Other display modules could include a printer or other output module.

Generally, the present invention is achieved in several steps, the orderof which may vary for a particular product. A general discussion ofseveral embodiments of the invention are discussed below, with morespecific embodiments discussed in relation to FIG. 4.

As shown in FIG. 4, algorithm 400 is a series of steps, some or all ofthe steps may be stored on a computer-readable medium that may beexecuted at a server, client terminal, or other processing device toimplement the present invention. Step 405 begins execution of thealgorithm. Step 406 shows that the medical provider receives aprescription for a medical therapy. For example, a medical therapyprovider may receive a prescription by telephone or by a facsimile or byelectronic means, such as an electronic mail (e-mail) message. Themedical therapy provider may also receive a prescription directly from apatient or a patient's representative in person or by mail. Similarly,the distributor may receive a request from a physician or a pharmacistby telephone, or by facsimile, or by electronic means such as anelectronic mail message, and in some cases, by mail or hand delivery.

Step 410 shows the requirement to describe the features of a substitutemedical therapy to the patient to obtain access to the substitutemedical therapy. The features of the substitute medical therapy may bedescribed by the medical therapy provider or another health careprofessional, primarily based on the approved labeling for the medicaltherapy. These features could include, for example, data regarding therisks and benefits associated with the medical therapy and therestricted access. These features may also include the specificrequirements for obtaining a certification from the patient'sprescribing physician, as well as the additional requirements foreligibility that are reviewed and assessed by the distributor. One ofadditional requirements could include, for example, diagnostic testsadministered to a potential patient. In the case of the teratogenic drugthalidomide, diagnostic tests may include a pregnancy test, if thepotential patient is a fertile female.

In some cases, a medical therapy provider may need to obtain dataregarding the procedures for delivering the substitute medical therapyto the patient with the prescription. Data may include the procedures orthe cost for obtaining the substitute medical therapy, including itsassociated restricted distribution program. Data may also include, forexample, certain relevant risk assessment documents that may be used byhealthcare personnel, e.g., physician, physician's assistant, nurse,nurse practitioner, pharmacist, or distributor to assess whether thepatient should be prescribed the substitute medical therapy, taking intoaccount the risk profile of the drug and the patient's condition. Forexample, if the substitute medical therapy is a teratogen, such asthalidomide, the relevant risk may be the potential to become pregnant,if the patient is a fertile female, or the potential to impregnate afemale, if the patient is a fertile male. If the substitute medicaltherapy is bosentan, as another example, the relevant risks may be thepotential for pregnancy or impregnating a female and hepatotoxicity. Inthese cases, the relevant risk assessment documents may include apatient's recent pregnancy test results, menstrual cycle history, or aquestionnaire with answers to a patient's sexual history, ability, andwillingness to use pregnancy prevention measures, such as condoms ororal contraceptives. Relevant risk assessment documents forhepatotoxicity, as another example, may include liver function testresults and a questionnaire with answers about a patient's alcoholconsumption and other dietary habits.

Step 430 determines whether the patient wants the substitute medicaltherapy. The patient's decision is based on the information provided instep 410, and may include any additional diagnostic tests that may berequired for the patient to determine whether the patient would beeligible for the substitute medical therapy. In the case of thalidomide,for example, if the patient is a fertile female, the patient may need toobtain an additional pregnancy test, if the prior pregnancy test wereoutdated for determining eligibility to initiate the substitute medicaltherapy. The patient's decision also may be motivated by his medicalinsurance coverage for the substitute medical therapy. For example, ifthe substitute medical therapy is a generic pharmaceutical, the genericpharmaceutical may cost the patient substantially less than the brandedproduct. The patient's decision further may be motivated by thepatient's perception of the benefits of the substitute medical therapyover the medical therapy for which he was originally prescribed. Forexample, a substitute medical therapy may offer a better dosing scheduleor delivery means. If the answer to step 430 is “yes”, line 432 leads tostep 435. If the answer to step 430 is “no”, line 415 leads to step 420.

Step 420 delivers the original medical therapy as prescribed to thepatient. In this situation, the patient has determined that thesubstitute medical therapy would not be in the patient's best interestat this time. As a result, there is no need for the further processingsteps in this invention, and the algorithm ends with step 497.

Step 435 obtains the required patient data and informed consent forreceiving the substitute medical therapy. The required data couldinclude the patient's social security number, home address, and otheridentifying information, medical history, or other information asrequired, such as a diagnostic test. In most instances, this data hasalready been obtained by the patient's prescribing physician. Thepatient's informed consent typically includes an authorization torelease the patient's medical records from the patient's prescribingphysician for the purpose of delivering the substitute medical therapy.The relevant data previously obtained from prescribing physician,therefore, may be used for the purpose of determining the patient'seligibility for the substitute medical therapy. The informed consentwill typically include representations by the patient that the patientwill follow the requirements for access to the substitute medicaltherapy. For instance, with thalidomide, a patient could agree to useone or more forms of birth control to prevent a pregnancy while takingthe drug.

Step 440 determines whether the patient's prescribing physician agreesthat the substitute medical therapy would be appropriate for the patientbased on the physician's prior prescription for medical therapy and anynew patient data and informed consent. The prescribing physician'sdecision is likely to include considerations for ease of transferring tothe substitute restricted access program and familiarity with thesubstitute medical therapy and its restricted access. If the physiciandetermines that the patient should be prescribed the substitute medicaltherapy under its conditions, typically, the physician must also certifythat the patient is qualifying for a prescription and that the physicianwill monitor and follow the requirements associated with the restricteddistribution of the substitute medical therapy. In some instances, thephysician's prescription alone may be sufficient to satisfy thiscertification requirement, depending on the specific medical therapyinvolved. If the answer to step 440 is “no”, line 445 leads to step 447.If the answer to step 440 is “yes”, line 450 leads to step 455.

If the physician determines that the patient does not qualify fordelivery of the substitute medical therapy, line 445 leads to step 447,where the physician would describe the features of the substitutemedical therapy and indicate why the physician determined that thepatient would not qualify to have the substitute medical therapydelivered at this time. In some instances, a patient could be qualifiedfor the substitute medical therapy at a future date. For example, in thecase of thalidomide, if a diagnostic test indicated that a patient werea pregnant female, the patient's physician could prescribe thalidomidein the future after the patient were no longer pregnant. As anotherexample, a patient that provided a deficient informed consent, e.g., thepatient did not agree to follow one or more of the requirements of therestricted distribution program for the substitute medical therapy,could in the future agree to those deficient requirements and becomequalifying for the substitute medical therapy. Step 447 then leads tostep 420.

Step 455 provides to the distributor certain preliminary information forthe distributor or a third party reviewer to consider whether thepatient with a prescription would be eligible for receiving thesubstitute medical therapy. In some instances, this information could beprovided by the patient's physician, based on the patient'sauthorization to release medical records in its informed consent. Someof this information, however, may be provided by the medical therapyprovider, e.g., the patient's authorization to release the patient'smedical records to deliver the substitute medical therapy. The data maybe received from a user terminal, web page, network device or othersource of image data or sample data, and is typically transmitted over anetwork or other transmission medium. For example, data would betypically obtained via facsimile from a doctor's office and sent to thedistribution party. The data would include the physician's prescriptionand certification (where applicable) and the patient's data, includingany required diagnostic tests, and patient's authorization and informedconsent. Some of this data may differ, depending on the particularpatient. For example with thalidomide, data associated with a fertilefemale patient would include a negative pregnancy test (negative,because if it were positive, the potential patient's physician would nothave found the patient qualifying for a prescription), whereas dataassociated with a fertile male patient would not include a negativepregnancy test.

The distribution party includes, in some aspects, the manufacturer thatactually makes the substitute medical therapy and its authorizeddistributors and marketers and their representatives. Making asubstitute medical therapy available for delivery to a patient with aqualifying prescription means performing some or all aspects of puttingan FDA approved substitute medical therapy on the market. For example,for a pharmaceutical such activities may comprise making the drugsubstance (API), making the drug product (formulation), testing the drugproduct for its stability and bioequivalency/clinical equivalency,preparing labeling materials, filing for approval with the FDA,preparing commercial quantities of the drug product, labeling materialsin anticipation of approval by the FDA, and distributing the drugproduct in interstate commerce to distributors, pharmacies, physicians,and patients.

Data may be provided in a variety of ways. For example, a pharmacist,upon receipt of a prescription for a pharmaceutical product with arestricted distribution program, may provide the prescription viafacsimile or by electronic means, e.g., using commercial software toscan the prescription into an electronic document to be sent by anelectronic mail message, to the distributor. In some aspects, thepharmacist may send the prescription (either transcribed, or original ora copy) to the distributor by courier or by mail or by hand delivery.

In step 460, the distributor confirms the informed consent provided bythe patient. For later verification purposes or quality control, thedistributor may choose to voice-record this conversation. Depending onthe requirements of the restricted distribution program, this step mayalso involve describing and/or explaining the features of the substitutemedical therapy or restricted access program to the patient. For examplewith thalidomide, this confirmation step could include verifying thatthe patient has been provided with and understands all of the necessaryinformation to provide informed consent, i.e., risks and benefits ofthalidomide, including its teratogenic effects, viewing or reading anyinstructional materials such as videotapes or product labelingbrochures, and the requirements applicable to this qualifying patientfor becoming eligible to receive thalidomide from the distributor. Inother instances, the distributor may gather additional information toconfirm the qualified patient's informed consent, which may then be usedfor the distributor to determine eligibility for delivery of thesubstitute medical therapy to this patient. For example, the distributormay gather additional information concerning the qualified patient'sconcomitant medication use or medical history, or willingness to complywith the requirements for delivery of the restricted access substitutemedical therapy.

Step 465 determines whether the qualified patient is eligible fordelivery of the restricted access substitute medical therapy by thedistributor. At this stage of the process, at a minimum the distributorhas reviewed the documents provided in step 455 and has confirmed orlistened to the voice-recording of the patient's informed consent instep 460. The distributor may require additional information at thisstage if, for example, the patient's informed consent indicates thatadditional information should be obtained from the patient's physician.The distributor may also routinely obtain certain information, such ascalling the qualified patient's medical insurance provider to verifytreatment for certain disease conditions or medical coverage for themedical therapy. This step includes evaluating the appropriateness of aprescription for a particular patient.

Evaluating the appropriateness of a prescription includes thedetermination made by the distributor, such as the manufacturer of thesubstitute medical therapy, upon receipt of relevant risk-assessmentdocuments from the prescribing physician. The manufacturer may havephysicians or pharmacists or nurses or other health care personnelevaluate the documents for appropriateness of the prescription. Forexample, if the drug is a teratogen, the prescription would becontraindicated if the patient is pregnant, and thus the prescriptionwould be inappropriate. Similarly, upon reviewing the documents and uponconsultation with the patient, the distributor may conclude that thepatient may not be willing or able to avoid pregnancy while on themedication, if the prescription were to be dispensed. Prescription wouldbe inappropriate in this case as well and the manufacturer may opt todeny the drug product or delay the delivery to a future date.

After the distributor makes its decision, if the answer to step 465 is“no”, line 451 leads to step 470. If the answer to step 465 is “yes”,line 475 leads to step 480.

Step 470 shows that the distributor will then inform the prescribingphysician that the qualifying patient was not found eligible for thesubstitute medical therapy. In some instances, line 471 shows thedistributor or pharmacist will then describe the features of asubstitute medical therapy in step 410 and proceed as before. Aqualified patient could become eligible for delivery by the distributorat a future date. For example, in the case of thalidomide, if thedistributor were unable to reach the qualified patient within a certaintime period, certain diagnostic tests related to requirements couldbecome outdated. In the case of thalidomide, a diagnostic test for aqualified female patient would be a negative pregnancy test. If thenegative pregnancy test were conducted outside the prescribed timeperiod, as indicated in the restricted distribution program, thequalified patient could become eligible for delivery by submitting acomplying pregnancy test to the distributor. As another example, apatient that provided a valid written informed consent but then wasunable to confirm the informed consent during the initial discussionwith the distributor in step 460 may subsequently confirm the informedconsent. In other instances, the patient may decide not to obtain themedical therapy and line 472 leads to step 497, where the algorithmends.

Step 480 delivers the substitute medical therapy to the patient. Forexample, the delivery may be by next day delivery with a return receiptand delivery only upon signature by the patient. In most instances, thedistributor will facilitate access to the medical therapy and provide ameans for verifying the delivery. The distributor may facilitate accessto the substitute medical therapy by any one of several means. Forexample, the substitute medical therapy may be sent by mail or courierto the patient or physician or their representatives. If the substitutemedical therapy is sent to the physician, the patient may pick it upfrom the physician's office, or the physician's office may mail orcourier the drug to the patient. Alternatively, the substitute medicaltherapy may be sent by the manufacturer to a pharmacy where the patientmight come by to pick it up in person. In another aspect, the pharmacymay also send the medical therapy by courier or by mail.

Step 485 determines whether the patient has received the substitutemedical therapy. Receipt may be verified by a return receipt with asignature. Alternative means may be used to confirm receipt, forexample, receipt by a receiving authority for the patient, including,but not limited to, the patient's physician or pharmacist. If the answeris “no” line 490, leads to step 465, where the distributor adds thisinformation along with the previously received information anddetermines whether the patient still meets the requirements for accessto the substitute medical therapy. At the distributor's discretion, insome situations, for example, the patient may be contacted to determinethe reason for non-receipt and re-authorize the delivery of thesubstitute medical treatment. In other situations, additional diagnostictests may be required (re-tests). In still other situations, thepatient's physician or both the patient and patient's physician may becontacted for additional information.

If the answer step 485 is “yes”, line 492 shows that step 495 isreached. Step 495 shows that the delivery of the substitute medicaltherapy to the patient will be confirmed and recorded. In step 495 thedata recorded may include, for example, a copy of the patient'sprescribing label, the patient's data and diagnostic tests andvoice-recorded confirmation of informed consent provided in step 460,and the reasons for determining that the qualified patient was eligiblefor delivery of the substitute medical therapy by the distributor. Ifcertain additional data is obtained verbally as part of a consultation,these discussions also may be voice-recorded and made part of thisrecord. These records may be printed, displayed, transmitted to alocation, such as a user terminal, other location designated by a user,or a memory coupled to the server, or processing device, executingcertain aspects of algorithm 400. For example, the prescription datarecorded in step 495 may be supplemented with additional prescribingdata for this or other medical therapies by the distributor. Inaddition, the prescription data may be accessed by the distributor,manufacturer of the substitute medical therapy, or other regulatory bodyfor quality control of the delivery process or for obtaining statisticalor other data, as described in other embodiments of the presentinvention.

The algorithm ends, as shown in step 497.

The following examples describe scenarios to illustrate how the proposedmethod may be used for providing a substitute medical therapy to apatient.

Example 1

Patient A is a 28 year old female and visits her physician B for aconsult. Physician B, after consultation, concludes that Patient A couldbenefit from using the drug thalidomide. Physician B then consultsPatient A, a woman of childbearing potential, and explains to her thatthalidomide is a teratogen and causes severe birth defects if a fetus isexposed to the drug, and explains all the precautions that need to betaken before starting the therapy and during the therapy, includinggetting pregnancy testing. After the consultation, Physician B also asksthe patient to watch the audiovisual program prepared by the currentmanufacturer, Company X. Patient A watches the audiovisual program andreads the written material provided by the Company X. A also signs aninformed consent stating that her physician B has explained the programto her, that she has read, seen and understood the teratogenic dangersof the drug, and that she is willing and able to follow instructionsrelating to avoiding pregnancy while on the medication, and that shewould comply with the program. Physician B then obtains a pregnancy testfrom Patient A, which confirms that Patient A is not currently pregnant.Physician B then writes a prescription for thalidomide. Patient A takesthe prescription to her local pharmacy.

Pharmacist C at the pharmacy informs Patient A that there is an FDAapproved generic pharmaceutical available from Company Y. Patient Adetermines that she would benefit from the generic substitute, e.g., itmay cost substantially less with her medical insurance. Pharmacist Cthen sends the prescription via facsimile to Company Y. Company Ycontacts Physician B and informs him that the patient has requested thegeneric substitute and requests copies of Patient A's relevant riskassessment documents, including the patient's medical history, includingtwo previous negative pregnancy test results, her informed consent, andrequests Physician B's certification that he will comply with theobligations of the risk management program for the generic substitutemedical therapy.

Upon receipt of the documents, Company Y's health care personnel,preferably a physician or pharmacist or nurse, counsels Patient A toconfirm she understands the risks, understands how to avoid pregnancywhile on the medication, and knows what to do in case she is unable tocomply with the program or suspects that she is pregnant while on themedication. In addition, Company Y also evaluates any potentialdrug-drug, drug-disease interactions that could compromise thetreatment, harm the patient, or produce false positive or false negativepregnancy tests. Company Y may choose to voice-record the entireconversation. If Company Y believes that Patient A is an appropriatecandidate for the thalidomide prescription, Company A then prepares tofill the prescription, makes the prescription label, affixes the labelto the container or box with the medication, includes the patient guideand other relevant parts of the labeling as required, and delivers it topatient via a courier or by express mail. Once the courier serviceconfirms that Patient A has received the medication, Company Y thenrecords the prescription information and patient information, stores allthe relevant risk assessment information, both electronically andphysically in an easily retrievable format. Company Y sends a letter toPhysician B that the prescription has been filled and the patient hasreceived it. Company Y also includes a copy of the prescription labelthat has been attached to the medication box that is shipped to PatientA, and a copy of the courier confirmation of Patient A's receipt.

Example 2

Example 2 is similar to Example 1 with respect to Patient A's diagnosis,treatment options, Physician B's activities and Patient A presenting theprescription to Pharmacist C. Pharmacist C then informs Patient A of thegeneric pharmaceutical option and Patient A agrees to have theprescription filled with the substitute. As in Example 1, Pharmacist Cproceeds to fill the prescription, and chooses the genericpharmaceutical product from Company Y. The difference here is that theprescription then gets transmitted electronically to Company Y by usingappropriate software on a secure network. Company Y retrieves theprescription information and contacts Physician B as described inExample 1. The rest of the procedure is the same as in Example 1.

Example 3

Example 3 is analogous to Example 1 but for the following differences:the restricted distribution drug is lenalidomide; the risk-assessmentrelates to preventing exposure to a fetus.

Example 4

Example 4 is analogous to Example 2 but for the following differences:the restricted distribution drug is lenalidomide; the risk-assessmentrelates to preventing exposure to a fetus.

Example 5

Example 5 is analogous to Example 1 but for the following differences:the restricted distribution drug is isotretinoin; the risk-assessmentrelates to preventing exposure to a fetus.

Example 6

Example 6 is analogous to Example 2 but for the following differences:the restricted distribution drug is isotretinoin; the risk-assessmentrelates to preventing exposure to a fetus.

Example 7

Example 7 is analogous to Example 1 but for the following differences:the restricted distribution drug is bosentan; the risk-assessmentrelates to assessing pregnancy and liver function.

Example 8

Example 8 is analogous to Example 2 but for the following differences:the restricted distribution drug is bosentan; the risk-assessmentrelates to assessing pregnancy and liver function.

Example 9

Example 9 is analogous to Example 1 but for the following differences:the restricted distribution drug is alosetron; the risk-assessmentrelates to preventing life-threatening ischemic colitis.

Example 10

Example 10 is analogous to Example 2 but for the following differences:the restricted distribution drug is alosetron; the risk-assessmentrelates to preventing life-threatening ischemic colitis.

Example 11

Example 11 is analogous to Example 1 but for the following differences:the restricted distribution drug is dofetilide; the risk-assessmentrelates to preventing drug-drug interactions or drug-diseaseinteractions that may induce life-threatening ventricular arrhythmia.

Example 12

Example 12 is analogous to Example 2 but for the following differences:the restricted distribution drug is dofetilide; the risk-assessmentrelates to preventing drug-drug interactions or drug-diseaseinteractions that may induce life-threatening ventricular arrhythmia.

Example 13

Example 13 is analogous to Example 1 but for the following differences:the restricted distribution medical therapy is a product with thepotential for substance abuse or chemical dependence, such as oxycodone,marijuana, and cannabis, and the risk assessment involves reducing therisk for such abuse.

Example 14

Example 14 is analogous to Example 2 but for the following differences:the restricted distribution medical therapy is a product with thepotential for substance abuse or chemical dependence, such as oxycodone,marijuana, and cannabis, and the risk assessment involves reducing therisk for such abuse.

Example 15

Example 15 is analogous to Example 1 but for the following differences:the restricted distribution medical therapy, such as clozapine or any ofthe preceding drugs, requires ongoing diagnostic testing for continuedtherapy.

Example 16

Example 16 is analogous to Example 2 but for the following differences:the restricted distribution medical therapy, such as clozapine or any ofthe preceding drugs, requires ongoing diagnostic testing for continuedtherapy.

Thus, while fundamental novel features of the invention shown anddescribed and pointed out, it will be understood that various omissionsand substitutions and changes in the form and details of the devicesillustrated, and in their operation, may be made by those skilled in theart without departing from the spirit of the invention. For example, itis expressly intended that all combinations of those elements and/ormethod steps which perform substantially the same function insubstantially the same way to achieve the same results are within thescope of the invention. Moreover, it should be recognized thatstructures or elements or method steps shown or described in connectionwith any disclosed form or embodiment of the invention may beincorporated in another form or embodiment. It is the intention,therefore, to be limited only as indicated by the scope of the claimsappended hereto.

1. A method executed by a computer processor for providing restrictedaccess to a generic drug by a medical therapy provider comprising: apharmacy receiving a prescription for a patient for a branded restricteddistribution drug prescribed by a physician, wherein the prescriptionhas been previously approved for fulfillment, and wherein a brandedrestricted distribution drug is a drug that requires compliance with aFood and Drug Administration (FDA)-approved risk management program; thepharmacy determining that a generic drug is available as a substitutefor the branded restricted distribution drug; the pharmacy contacting amanufacturer of a generic drug available as a substitute for the brandeddistribution drug; the generic drug manufacturer: determining theeligibility of the patient for the generic drug in compliance with anFDA-approved drug risk management program for the generic drug;obtaining approval, if necessary, from the prescribing physician tosubstitute the generic drug for the branded distribution drug;authorizing the fulfillment of the generic drug to the patient onlyafter determining that the patient is eligible and, if necessary, afterobtaining the approval from the prescribing physician to substitute thegeneric drug for the branded restricted distribution drug, wherein thefulfillment may be provided by one of: the pharmacy, the prescribingphysician, the generic drug manufacturer, or a distributor, and whereinthe distribution of the generic drug is not authorized if the patient isdetermined to be ineligible; after authorizing the fulfillment of thegeneric drug to the patient, recording data associated with the patient,the eligibility determination of the patient for the generic drug, andthe fulfillment of the generic drug in a computer-readable medium; andwherein the authorizing the fulfillment of the generic drug to thepatient does not comprise: the generic drug manufacturer or distributorgenerating a prescription approval code prior to fulfillment of theprescription; or requiring the patient, the pharmacy, or the prescribingphysician to be registered with the generic drug manufacturer ordistributor prior to the fulfillment of the prescription.
 2. The methodof claim 1, wherein the generic drug is a product with the potential forsubstance abuse or chemical dependence.
 3. The method of claim 1,wherein the generic drug requires ongoing diagnostic testing forcontinued therapy.
 4. The method of claim 1, wherein the generic drug isthalidomide.
 5. The method of claim 1, wherein the generic drug islenalidomide.
 6. The method of claim 1, wherein the generic drug isisotretinoin.
 7. The method of claim 1, wherein the generic drug isbosentan.
 8. The method of claim 1, wherein the generic drug isalosetron.
 9. The method of claim 1, wherein the generic drug isdofetilide.
 10. The method of claim 1, wherein the generic drug isoxycodone.
 11. The method of claim 1, wherein the generic drug iscannabis.
 12. The method of claim 1, wherein the generic drug isclozapine.
 13. A method executed by a computer processor for providingrestricted access to a generic drug by a generic drug manufacturer ordistributor comprising: receiving a request for distribution of thegeneric drug for a specific patient, wherein the prescription has beenpreviously approved for fulfillment as a branded restricted distributiondrug prescribed by a physician, and wherein a branded restricteddistribution drug is a drug that requires compliance with a Food andDrug Administration (FDA)-approved risk management program; obtainingrelevant risk-assessment documents from the prescriber who originatedthe request for the patient; the generic drug manufacturer ordistributor: determining the eligibility of the patient for the genericdrug in compliance with an FDA-approved drug risk management program forthe generic drug; obtaining approval, if necessary, from the prescribingphysician to substitute the generic drug for the branded distributiondrug; facilitating access of the generic drug to the patient only afterdetermining that the patient is eligible, and wherein the distributionof the generic drug is not facilitated if the patient is determined tobe ineligible; after facilitating access of the generic drug to thepatient, recording data associated with the prescription, theeligibility determination of the patient for the generic drug, and thegeneric drug provided in a computer-readable medium; and wherein thefacilitating access of the generic drug to the patient does notcomprise: the generic drug manufacturer or distributor generating aprescription approval code prior to providing the generic drug; orrequiring the patient, the pharmacy, or the prescribing physician to beregistered with the generic drug manufacturer or distributor prior toproviding the generic drug.
 14. The method of claim 13, wherein thegeneric drug is a product with the potential for substance abuse orchemical dependence.
 15. The method of claim 13, wherein the genericdrug requires ongoing diagnostic testing for continued therapy.
 16. Themethod of claim 13, wherein the generic drug is thalidomide.
 17. Themethod of claim 13, wherein the generic drug is lenalidomide.
 18. Themethod of claim 13, wherein the generic drug is isotretinoin.
 19. Themethod of claim 13, wherein the generic drug is bosentan.
 20. The methodof claim 13, wherein the generic drug is alosetron.
 21. The method ofclaim 13, wherein the generic drug is dofetilide.
 22. The method ofclaim 13, wherein the generic drug is oxycodone.
 23. The method of claim13, wherein the generic drug is cannabis.
 24. The method of claim 13,wherein the generic drug is clozapine.
 25. A method executed by acomputer processor for delivering a substitute medical therapy productcomprising: receiving a prescription for a patient for a brandedrestricted distribution medical therapy prescribed by a physician,wherein the prescription has been previously approved for fulfillment,and wherein a branded restricted distribution medical therapy is amedical therapy that requires compliance with a Food and DrugAdministration (FDA)-approved risk management program; determining thata substitute medical therapy is available as a substitute for thebranded restricted distribution drug; describing features to obtain thesubstitute medical therapy for a qualifying patient for whom the brandedmedical therapy is prescribed; contacting a manufacturer of a substitutemedical therapy available as a substitute for the branded medicaltherapy; the substitute therapy manufacturer: obtaining data andpatient's informed consent to receive the substitute medical therapy forthe branded medical therapy, wherein the consent includes anauthorization to release the patient's medical records to deliver thesubstitute medical therapy; providing, to the distributor of thesubstitute medical therapy, the authorization, certification data,informed consent and required diagnostic tests, wherein thecertification data includes conclusions from the prescribing physicianthat the patient is a qualified patient for the substitute medicaltherapy and representations that the prescribing physician will followthe requirements of the restricted access program for the substitutemedical therapy; confirming the informed consent from the qualifiedpatient to the distributor of the substitute medical therapy;determining the eligibility of the patient for the substitute medicaltherapy by the distributor of the substitute medical therapy incompliance with an FDA-approved drug risk management program for thesubstitute medical therapy; obtaining approval, if necessary, from theprescribing physician to substitute the substitute medical therapy forthe branded medical therapy; delivering the substitute medical therapyto the eligible patient only after the distributor of the substitutemedical therapy determining that the patient is eligible, and whereinthe distribution of the substitute medical therapy is not authorized ifthe patient is determined to be ineligible; after delivering thesubstitute medical therapy to the patient, recording data associatedwith the prescription, patient, the eligibility determination of thepatient for the substitute medical therapy, and the delivery of thesubstitute medical therapy in a computer-readable medium; and whereinthe delivery of the substitute medical therapy does not comprise: thesubstitute medical therapy manufacturer or distributor generating aprescription approval code prior to delivering the substitute medicaltherapy; or requiring the patient, the pharmacy, or the prescribingphysician to be registered with the substitute medical therapymanufacturer or distributor prior to the delivery of the substitutemedical therapy.
 26. The method of claim 25, further comprising:obtaining data regarding a procedure for delivering a substitute medicaltherapy.
 27. The method of claim 25, further comprising: confirming andrecording prescription data including the prescription label.
 28. Themethod of claim 25, further comprising: obtaining additional data fromthe qualified patient to determine present or future qualification oreligibility for the substitute medical therapy.
 29. The method of claim25, wherein the substitute medical therapy is a product with thepotential for substance abuse or chemical dependence.
 30. The method ofclaim 25, wherein the substitute medical therapy requires ongoingdiagnostic testing for continued therapy.
 31. The method of claim 25,wherein the substitute medical therapy is thalidomide.
 32. The method ofclaim 25, wherein the substitute medical therapy is lenalidomide. 33.The method of claim 25, wherein the substitute medical therapy isisotretinoin.
 34. The method of claim 25, wherein the substitute medicaltherapy is bosentan.
 35. The method of claim 25, wherein the substitutemedical therapy is alosetron.
 36. The method of claim 25, wherein thesubstitute medical therapy is dofetilide.
 37. The method of claim 25,wherein the substitute medical therapy is oxycodone.
 38. The method ofclaim 25, wherein the substitute medical therapy is cannabis.
 39. Themethod of claim 25, wherein the substitute medical therapy is clozapine.40. The method of claim 25, further comprising: obtaining additionaldata from the qualified patient for quality control.